Press Room

Article / Sep 17, 2009

Welcome speech by Guy Villax at the 6th Hovione Seminar

The event that marked the start of the celebrations of Hovione's 50th anniversary.

Welcome speech by Guy Villax, Chief Executive, to the attendees of the 6th Hovione Seminar.

Estoril, 17th September 2009

Ladies and Gentlemen – Good Morning and Welcome,

I am delighted that you all came from far away to be here with us to celebrate the 50th anniversary of Hovione. Thank you. I am so glad to see so many faces – from so many moments – recent relationships and very long standing ones. Only a moment ago Gerold Stamm was telling me my father supplied him with doxycycline in 1979.

In 2007, I was a witness before a sub-committee of Congress and I said that for 40 years I had had a front seat watching the growth and evolution of the pharmaceutical industry. There have been endless changes, but what I feel is most important is to do with people.

For a long time careers would last a shorter time than the lives of companies, today it is the other way around. Most careers last far longer than companies. Among many stories that shaped Hovione, the one about us supplying Agouron with Viracept stands out as a good example. When the original 10 tons per year forecast became a 100 ton per year challenge, Hovione rose to the occasion. We were trusted to do the impossible, we committed to do our best, and together we came though and delivered a $500m sales product in the 1st year. Agouron was so successful it was bought by Warner Lambert, then by Pfizer. But still today many of the people that worked with us then to do the impossible -and made sure the market was never short of product- are now working in many other biotechs across California and they have great memories of what collaborations can achieve. The Agouron story was -to me- the first evidence that the outsourcing model not only worked, reduced risk and cost but that it was also robust and able to meet the toughest challenge. Viracept at some stage mobilised 1000m3 of reactor capacity.

So business is about networks, people that trust each other and work together to achieve great things.

Second listening to customers is not easy. In addition to listening carefully one has to really understand the client’s context. Unless we are familiar with the driving forces that shape decisions within a customer we will never be able to be proactive and truly become aligned with it. The most challenging aspect of the future way of working in the pharmaceutical industry is how to work collaboratively. The “procurement” model will soon be dead because the Parma Industry is now facing for the first time ever strong Darwinian pressures. The need to survive will drive evolution and only the fittest will succeed, the issue here is not being the best among equals – the winner will be of a new shape, working in a new way. But it takes two to tango, so a new shape of supplier to emerge we need a new shape of customer.

Third – again people, people make things happen. At the top big decisions get taken, but the outcome is to do with execution, Getting it done, right first time – every time is a matter for everyone in the company – and it is especially at the operations level, whether in the lab or operating reactors, that actions are taken that result in good yields or not, in deviations or not, in surprises – better good than bad. You can only procedurise so far, you need to count on the human side – to do this you need great people. This does not happen by chance, it is not determined by culture, or nationality, or even by education – it is a matter of leadership, of somehow providing everyone in the company with a sense of belonging, making work meaningful.

Nothing gives our work more sense than when we are told what our products do for patients. Yesterday a customer told me he has a desk full of letters from parents of children that suffer from cystic fibriosis. This is a terrible illness, these kids probably never had a good night’s sleep in their life. Peter was telling me that after 3 weeks on the new drug, they sleep – their life is changed. Hovione is part of that effort, this is why we are here.

There are many people that should be mentioned as key in our first 50 years. Whether as customers giving us business and opportunities to make a difference, or as team members developing the solutions and manufacturing the products. The way we will show our appreciation is by focusing on the work ahead, making sure Hovione continues to do a good job.

Thank you
Guy Villax
Chief Executive
Hovione

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Continuous Tableting (CT) is defined as continuous manufacturing of oral dose drugs, specifically tablets. As per ICH's Q13 definition1, a continuous manufacturing process in the pharmaceutical industry comprises at least two unit operations integrated from a mechanical and software perspective. There is a wide combination of possible CT process configurations that are dependent on the needs of the intended product formulation and each of the individual unit operations that constitute the process train can be continuous, semi-continuous, or batch processes. The typical manufacturing processes for tablet formulation are direct compression (DC), dry granulation (DG) and wet granulation (WG)2 - details on these manufacturing processes are beyond the scope of this article, so the interested reader is directed to relevant literature. The actual implementation of CT technology in a facility can broadly vary depending on the level of desired integration and automation. Process trains can be designed to be flexible and converted between multiple configurations (e.g. continuous DC, DG and WG), controlled by the end user from one single software and within a single clean room. The other possibility would be for subsections of the CT process to be divided into multiple clean rooms where inprocess materials are transferred between suites via a bin-to-bin approach (e.g. a granulation suite to prepare granules from raw materials followed by continuous DC (CDC) to blend the granules and produce tablets). The level of automation and instrumentation designed into the CT process (typically involving Process Analytical Technologies, PAT) can open the possibility to implement sophisticated control strategies. Key components of a control strategy that need to be considered for CT are material tracking and genealogy, knowledge of the residence time distribution (RTD), and in-process controls (spectroscopic and/or soft sensors based on process parameters). Holistically, these control strategy elements enable the implementation of a material diversion strategy to automatically divert out of specification material from the process. In their most advanced form, control strategies may also enable real time release testing (RTRt) of the final tablet drug product and reduce the off-line analytical burden and the number of operators needed to manage the process.   Read the full article at gmp-journal.com  

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